NCT06097247

Brief Summary

The study examines potential adverse side effects on family functioning and parent-child relationships of standard treatment family-based therapy (FBT) for anorexia nervosa (AN) in children and youths.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
15mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Feb 2022Aug 2027

Study Start

First participant enrolled

February 1, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

4.5 years

First QC Date

October 18, 2023

Last Update Submit

August 14, 2025

Conditions

Anorexia in AdolescenceAnorexia in ChildrenFamily Relations

Outcome Measures

Primary Outcomes (3)

  • The Systemic Clinical Outcome and Routine Evaluation - 15 items version (SCORE-15).

    Minimum value: 1 Maximum value: 5 Higher scores mean worser outcome.

    Start and End of Treatment (an average of 1 year).

  • The Kerns Security Scale-Revised 21

    Minimum value: 1 Maximum value: 4 Higher scores indicate more secure attachment.

    Start and End of Treatment (an average of 1 year).

  • Difficulties in Emotion Regulation Scale (DERS)

    Minimum value: 1 Maximum value: 5 Higher scores mean worser outcome.

    Start and End of Treatment (an average of 1 year).

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All eligible patients presenting for treatment in the region are invited to participate.

You may qualify if:

  • Diagnosis of F50.0 or F50.1 first time of treatment with family-based treatment living with a minimum of one parent informed consent from young person and parents

You may not qualify if:

  • non Danish-speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child and Adolescent Mental Health Care Center

Copenhagen, DK-2400, Denmark

Location

Study Officials

  • Anne Katrine Pagsberg, professor

    Child and Adolescent Mental Health Care Centre, Capital Region of Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 24, 2023

Study Start

February 1, 2022

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)